Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair

Prospective, Randomized Study Comparing General Anesthesia Combined With Locoregional Anesthesia to Locoregional Anesthesia Alone for Arthroscopic Rotator Cuff Repair.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07093905

Acronym

ALRAGA

Enrollment

Registered

2025-07-30

Start date

2026-03-12

Completion date

2027-04-30

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Syndrome

Brief summary

The purpose of this study is to to compare the post-anesthetic recovery time to awake consciousness and hemodynamic and ventilatory capacities for discharge from the Post-Interventional Monitoring Room in patients admitted for shoulder rotator cuff arthroscopy (using local anesthesia versus general anesthesia + local anesthesia).

Detailed description

This is a prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies used in outpatient, routine surgery. The study population is composed of adult patients with complete or partial rotator cuff tears requiring reconstructive surgery under anesthesia at Hôpital Privé Clairval or Clinique Monticelli-Vélodrome. Patients will be seen three times: at inclusion (during the preoperative consultation with the anesthetist), on the day of surgery (hospitalization), and at the follow-up visit (during the postoperative consultation with the surgeon). They will also be contacted by telephone on D1, D3 and D15 to optimize their follow-up. The duration of each patient's participation is approximately one month.

Interventions

PROCEDUREarthroscopy of the shoulder rotator cuff

minimally invasive surgical procedure in which a camera (arthroscope) is inserted into the shoulder joint

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

open-label study

Intervention model description

Prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years; * Patients with surgically repairable complete or partial rotator cuff tears; * American Society of Anesthesiologists Class I to III; * Patient able to understand study information; * Patient willing to accept study evaluations and follow-up visits; * Affiliation with a social insurance plan; * Patient having been informed and having agreed to participate in the study by signing an informed consent form.

Exclusion criteria

* Contraindication to general or locoregional anesthesia; * Chronic opioid use; * Patient unable to understand study information (linguistic, psychological, cognitive, etc.); * Patient unable to answer a self-questionnaire; * Patient participating in or being excluded from another interventional research study; * Pregnant or breast-feeding women; * Protected patient (under legal protection, guardianship or deprived of liberty by judicial or administrative decision).

Design outcomes

Primary

Measure	Time frame	Description
length of stay in the Post-Interventional Monitoring Room	Day 0	The primary endpoint is the length of stay in the Post-Interventional Monitoring Room from discharge from the operating room to an Aldrete score \> 8 leading to discharge from the Post-Interventional Monitoring Room.

Countries

France

Contacts

CONTACTMatthieu CHIVOT, MD

chivot.matthieu@gmail.com662347636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026